A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure With Normal Ejection Fraction
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in left ventricular filling pressures (E/e') assessed by echocardiography
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome.
The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.
Detailed Description
In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the immunomagnetic positive selection of the CD34+ cells.
Investigators
Bojan Vrtovec
Medical Director, Advanced Heart Failure and Transplantation Programme
University Medical Centre Ljubljana
Eligibility Criteria
Inclusion Criteria
- •Preserved left ventricular systolic function on echocardiography (LVEF\>50%)
- •Evidence of diastolic dysfunction by echocardiography (E/e'\>15)
- •Symptoms of heart failure
- •NT-proBNP levels \>300 pg/ml
- •absence of permanent atrial fibrillation
Exclusion Criteria
- •acute multi-organ failure
- •history of any malignant disease within 5 years
- •diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
- •pregnancy
Outcomes
Primary Outcomes
Change in left ventricular filling pressures (E/e') assessed by echocardiography
Time Frame: Baseline, 6 months and 1 year
The E/e' ratio will be calculated from early transmitral velocity divided by peak left ventricular relaxation velocity for estimation of the left ventricular filling pressure.
Secondary Outcomes
- Change in diastolic dysfunction grade(Baseline, 6 months and 1 year)
- Change in exercise capacity(Baseline, 6 months and 1 year)
- Change in NT-proBNP levels(Baseline, 6 months and 1 year)
- Change in systolic strain(Baseline, 6 months and 1 year)